Senior Systems Engineer

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R•Santa Clarita, CA

12h•$121,000 - $134,000•Onsite

About The Position

We are seeking an experienced Senior Systems Engineer to support the development of advanced medical device technologies from concept through commercialization. As a key member of the Systems Engineering team, this role will collaborate closely with Research & Development, Clinical, Quality, Manufacturing, Software, Electrical, Firmware, and Mechanical Engineering teams to ensure successful product development and system integration. The ideal candidate will have a strong background in systems engineering within a regulated medical device environment and experience translating clinical and business needs into engineering requirements, managing system-level risks, and leading verification and validation activities. This role requires a highly collaborative and self-directed engineer capable of leading multiple projects while ensuring the delivery of safe, effective, and high-quality products.

Requirements

Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Biomedical Engineering, or a related engineering discipline.
Strong understanding of systems engineering principles and multidisciplinary product development.
Experience developing system requirements, specifications, and engineering documentation.
Experience performing verification and validation activities within a regulated environment.
Knowledge of risk management methodologies and system-level hazard analysis.
Proficiency with laboratory test equipment and measurement tools.
Strong analytical, problem-solving, and troubleshooting skills.
Excellent written and verbal communication skills.
Ability to work independently and lead multiple projects simultaneously.

Nice To Haves

Experience in FDA Class III medical device development.
Experience with active implantable medical devices.
Familiarity with requirements management tools and processes.
Knowledge of electronics, embedded firmware, battery-powered systems, RF circuits, sensors, and mechanical systems.
Experience with low-power electronic systems.
Firmware development experience.
Prior experience with system architecture, integration, and reliability engineering.
Experience working in a highly regulated medical device environment.

Responsibilities

Translate clinical and customer needs into measurable engineering requirements and ensure traceability through verification and validation activities.
Develop and maintain system requirements, specifications, and design documentation.
Perform risk management activities in accordance with ISO 14971, including hazard analysis, risk assessments, and mitigation planning.
Lead cross-functional system integration efforts involving mechanical, electrical, firmware, software, and sensing technologies.
Research, design, develop, prototype, and test system-level solutions.
Develop verification and validation plans, protocols, and reports to demonstrate compliance with product requirements and regulatory expectations.
Plan and execute system safety and reliability testing activities.
Analyze test data and system performance to identify opportunities for improvement and ensure compliance with performance specifications.
Collaborate closely with Software, Firmware, Electrical, Mechanical, Quality, Manufacturing, and Clinical teams throughout the product development lifecycle.
Support design reviews, root cause investigations, technical assessments, and engineering decision-making.
Perform cost and performance analyses for new and existing products.
Develop and implement innovative tools, methodologies, and processes to improve engineering efficiency and product quality.
Design experiments, test fixtures, and data collection methods to support product development and research activities.
Lead multiple engineering projects and ensure timely execution of project deliverables.